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The Efficacy and Safety of Combined Therapy With Red Yeast Rice and Low-dose Statin：Comparing With Standardized Statin

NCT02726555 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-08-06

No results posted yet for this study

Summary

Double-dose statin regimen achieves merely 6% of decrease in low-density lipoprotein cholesterol (LDL-C) levels, whereas the risk of side effects increased largely. The investigators' previous pilot study (NCT01686451) has suggested that red yeast rice was of similar lipid-lowering efficacy while was associated with less fatigue than statins. The purpose of this study is to evaluate the efficacy and safety of combined therapy with red yeast rice and low-dose atorvastatin in persons with mild atherosclerotic cardiovascular disease and who qualified for statin therapy according to national guidelines.

Conditions

Interventions

DRUG

Red yeast rice and atorvastatin

Participants will receive 2 capsules of 300mg red yeast rice and 2 capsules of 10mg atorvastatin for 24 weeks.

DRUG

Atorvastatin alone

Participants will receive 2 capsules of placebo and 2 capsules of 10mg atorvastatin for 24 weeks.

Sponsors & Collaborators

  • Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Kangting Ji, MD · The Second Hispital of Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02726555 on ClinicalTrials.gov